Patients with colonised carbapenemase-bearing Klebsiella pneumoniae Infections and Infestations
Conditions
Interventions
The intervention arm will involve patients taking the probiotic (as below). The control arm involves no intervention
there is no placebo so patients will be discharged without a supplement/probiotic.
The probiotic preparation to be used will be BioGaia Gastrus tablets (BioGaia AB, Stockholm, Sweden)
Sponsors
Manchester University NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Male or female; aged 18 years or older 3. Immunocompetent as per medical history 4. TCD-KP detected on rectal screening in the last 2 months 5. Not currently hospital inpatient (when planning starting probiotic supplementation) All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation except where the study inclusion and exclusion criteria EXPLICITLY state otherwise.
Exclusion criteria
Exclusion criteria: 1. Any active infection at the time of enrolment 2. Presence of or likely to develop mucositis on examination, as per medical history 3. History of Presence cardiac prostheses 4. Consumption of any marketed probiotic product in the 30 day period prior to enrolment and during the duration of the trial 5. Consumption of Over the Counter (OTC) medication or herbal remedies labelled as to improve your immunity system or “for daily immunity” 6. In receipt of systemic or intestinal antibiotic within 14 days before baseline samples to be taken 7. Receiving or intended to receive antibiotic within 30 days of 1st baseline sample 8. Current and past history of pancreatitis 9. Concurrent melaena 10. Abdominal surgery within the 3 months prior to study enrolment 11. Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy 12. Any medical condition, which in the opinion of the Investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study 13. Past medical history of Severe renal dysfunction at Visit 0, defined as e GFR 3 times the ULN or alkaline phosphatase >2.5 times the ULN 15. Known hypersensitivity to any of the components of the probiotic. 16. Pregnancy, lactation or planning pregnancy. A pregnancy test will not be required before study enrolment, however, if a woman determines that she is pregnant during the study period, she must stop the probiotic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The feasibility of initiating studies in the secondary care setting, by identifying potential participants but study interventions carried out in the community 2. The feasibility of conducting a randomised controlled trial in immuno-competent adults known to be colonised with multi-resistant K pneumoniae and an assessment of recruitment and retention rates over a 12 month period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Faecal counts of multi-resistant Klebsiella pneumoniae measured using faecal sampling and culture at day 0 and day 21±2 2. Faecal counts of carbapenemase-bearing Klebsiella pneumoniae measured using faecal sampling and culture at day 0 and day 21±2 | — |
Countries
United Kingdom
Contacts
Public ContactBradley Tallon
Outcome results
None listed